K191235 is an FDA 510(k) clearance for the Leltek Ultrasound Imaging System. This device is classified as a System, Imaging, Pulsed Doppler, Ultrasonic (Class II - Special Controls, product code IYN).
Submitted by Leltek, Inc. (New Taipei City, TW). The FDA issued a Cleared decision on February 12, 2020, 280 days after receiving the submission on May 8, 2019.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1550.
| 510(k) Number | K191235 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 08, 2019 |
| Decision Date | February 12, 2020 |
| Days to Decision | 280 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IYN - System, Imaging, Pulsed Doppler, Ultrasonic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1550 |